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Quality Management Certification

Obtaining quality management certification is widely touted as a way for life science companies and other regulated manufacturers to gain a competitive edge in today's crowded global marketplace, and with good reason; International Standards Organization (ISO) and International Electrotechnical Commission (IEC) standards set the benchmark for product safety and success. Regardless of which regulated industry you operate in, becoming certified by a third-party certification body or registrar, either on your own or with the help of experienced quality process or ISO consultants, assures potential customers that you value quality, and your products conform to the highest regulatory standards. This assurance can lead to tremendous marketing and business advantages.

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MasterControl Quality Management System (QMS) Overview

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25 Free Resources to Boost Your Quality Management System

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Get insider information about the most relevant issues, and how to navigate and overcome the complexities of FDA regulations.

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FDA及びISO対策をマネジメントシステムで最適化する6つのポイント

Engineering and Quality Teams in Medical Device Firms: Can We All Get Along?

Automating Quality Compliance and Business Process within the Food and Beverage Industry

5 Tips for Getting Executive Backing for a New or Expanded EQMS

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Compliance and Technology: How to meet changing FDA expectations

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A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences (LNS Research)

Benefits of Certification

Being certified in quality management has many benefits; one of the biggest is the worldwide recognition your company will gain for its commitment to quality, safety, and sound quality management processes. Whether you opt to obtain certification using in-house resources/consultants, or enlist the services of external quality and/or ISO consultants to guide you through the certification process, demonstrating compliance with an internationally recognized standard, such as ISO 13485 or IEC 60601-1, will make it easier to conduct business in foreign markets and overcome many of the technical barriers to trade. Because more and more companies are looking to emerging markets (APAC, South America, India, and China, for example) for growth opportunities, quality management certification consultants and ISO consultants who are familiar with international standards and accreditation procedures can be of great value to regulated organizations hoping to leverage certification to stand out from the crowd. Here are just a few of the benefits certification may bring to your organization:

Increased Brand Equity - Understanding and implementing the processes and procedures necessary to obtain quality management certification will help you sustain your delivery of high-quality products and avoid embarrassing product recalls and regulatory sanctions. Ultimately, this will lead to increased brand equity, which is an important competitive advantage.

Enhanced Marketing and Promotional Opportunities - A company is found to be ISO compliant when it follows the guidelines issued by ISO, which can be found online. If you have difficulty understanding these guidelines, consider hiring ISO consultants who can assist you with the application process. Once you have been deemed compliant by a certified ISO registrar, you will receive a certificate which your marketing team will be able to display on all corporate marketing materials to enhance your credibility in the eyes of customers, employees, and other stakeholders. Other quality management certifications offer you similar marketing advantages.

Enhanced Customer Satisfaction - Technological innovations, such as the Internet and social media, have given rise to more sophisticated consumers and a more competitive global market. Only organizations that are able to demonstrate product superiority will be able to win sales and retain customers. Third-party certification to a particular standard or regulation assures consumers, as well as suppliers and foreign trade officials, that your business operations are safe and efficient.

Expedited Knowledge to Change - A key strength of the ISO standards is that they are created the people who need and use them. Those who have gone through the certification process, i.e., worked with experienced ISO consultants to understand the standards and what it takes to satisfy them, can participate in the development of standards, aka standards development. Involvement in standards development allows you to bring your concerns to the table and offers you early access to information that might impact your business in the future.

Reduced Risk and Internal Costs - Adopting the processes and procedures necessary to obtain certification in quality management will help you increase efficiency and improve your quality of operations, resulting in a better bottom line. One added advantage of pursuing certification to ISO 13485, for example, with the assistance of ISO consultants

Reduced Carbon Footprint - Much like automating your paper-based quality processes helps reduce paper waste, quality management certification promotes a lean business operation, which offers many environmental benefits. Best-in-class manufacturers are quickly discovering how the green marketing angle can be used to their promotional advantage.

Different Types of Quality Management Certification

There are many different types of quality management certification available. ISO, for example, has established more than 19,500 standards, covering almost every topic or process imaginable, and comprises over 140 national standards bodies. In addition to ISO, there is a whole strata of national and international standards organizations. Knowing what certification / accreditation is right for your business can be difficult to determine, which is why many companies rely on ISO consultants and other quality experts to help them navigate the arduous and time-consuming path to certification.

ISO Certifications - Undoubtedly the most influential standards body in the world, ISO's mission is to promote “the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technical and economic activity.” Some of its most popular standards are ISO 10993, ISO 13485, ISO 14155, ISO 14971, ISO 9001, but there are many others.

The benefits of certification are undeniable, so why isn't every company pursuing it? It addition to not knowing which certification is right for their business; many companies simply do not have the time, resources, or expertise to assess their entire QMS and identify and correct the issues and potential barriers to achieving certification success. Preparing for a third-party accreditation audit is a long and tedious process. Forming an alliance with an experienced, well-respected team of ISO consultants and/or quality management certification experts, such as MasterControl Quality and Compliance Consulting (QCC) will dramatically simplify the process. You'll enjoy the business and operational benefits of certification without the added stress and disruptions. QCC is comprised of a highly experienced team of QMS experts, auditors, certifiers, process engineers, and educators who not only know the life sciences and manufacturing industries inside and out, but also understand your business and the unique demands of regulated companies like yours. Our ISO consultants and quality experts provide guidance in seven core regulatory, compliance, and quality disciplines:

品質管理システム

薬事における承認及びコンプライアンス

Quality Process Training

サプライチェーンの管理

バリデーション／適格性確認

Certification/Accreditation Assistance

新製品の承認

Additional Benefits of Working With QCC

QCC offers you access to a global team of accreditation partners, ISO consultants, and other quality management experts. Your QCC expert will sit down with you to determine the scope of your needs and certification goals. After this initial assessment, we'll create a custom proposal that will guide you through every stage of the certification process. Whether you're interested in new product certification, quality system certification, or a host of other certifications, we can help you by customizing the quality management certification process to suit your business. But our work doesn't stop there; we can also provide you with on-going to support to ensure that you maintain your certification. Post-certification services include: internal auditing, training, and acting as a liaison between you and accreditation bodies.

For more information

Whether you're starting the quality management certification process, still weighing the benefits, or just want to discuss options for your business, contact us today.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.